Regeneron Pharmaceuticals Inc at BMO Biopharma Day: Spotlight on Rare Disease and Ophthalmology (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Well, thank you for being here. I think this will be a great discussion. As Justin said, this is going to largely focus on EYLEA. And maybe just to get things started, Justin, as you pointed out, it's been a remarkable year, strong growth. EYLEA in particular, was really durable in 2020. I see volumes are back to pre-COVID levels. Would love to get a sense of what you're seeing most recently in terms of mix, new versus existing patients, and any color you can share on the existing indications, within the individual indications as well would be great, just to sort of help catch us up on how things are looking today.

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : And there's been some at least sporadic shortages of Avastin. So maybe how has that helped EYLEA? And do you expect -- is it a reasonable assumption to assume that a patient who hopped over to EYLEA say from Avastin is now going to be sticky as a -- and remain on EYLEA as the sort of support of Avastin supply stabilizes?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Okay. And you mentioned diabetic eye disease, and we've -- it's been a topic of conversation for a while now, how to move the needle there, patient education, physician education, getting patients to actually seek treatment. How does Regeneron really actually grow the opportunity? And what does it take to actually move the needle from here?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : And is -- these are things that have been kind of discussed in the past. Is it now on the back end -- we're through COVID, growth remains as important as ever that this area is taking a greater level of prioritization within the company, driving diabetes relative to some of the other indications? Or is it a new strategy even within awareness that's going to help us? I'm just trying to understand a little better what gives you guys the confidence that these efforts will work in this space where it's been challenging up until now.

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Got it. I mean this is -- retinal disease and indications where EYLEA is approved or obviously, faced a lot of competition. It's evolving pretty rapidly. I guess as the market leader or the incumbent, how does EYLEA maintain its position in the market going forward? And what do you see as -- your competitors will have plenty of marketing messages. What do you see as the most effective kind of counter detailing message? And perhaps embedded in that, there was the brolucizumab safety data from a couple of -- I guess it was last month now, so how does something like that play to EYLEA's advantage? Sort of a commercial question then it started to become a clinical one for me ultimately.

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : And that's probably a good way to transition over to Neil. Certainly, one of the things that we're looking forward to towards the end of the year is the Phase II high-dose data, (inaudible) then, I believe. Maybe first things first, just walk us through the biologic rationale for the high-dose formulation. And what -- I mean, frankly, what gives you confidence that the study is going to work?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : And so I guess, to your point, we're going to be getting -- it's 8- and 12-week intervals. You mentioned something about anatomical end points. I guess what measures do you -- does Regeneron expect to communicate at the time, I guess, at least initially of top line release? And as always, that age-old investor question, right, what is the definition of good data? And probably built into that is this inherent thought, which is part of the purpose of the Phase II is to help with Phase III, right? And the Phase III is already ongoing. So how does 8- and 12-week Phase II data help set expectations around the Phase III study as well? So there's a couple of different phases of information.

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Okay. And maybe just talk a little bit more around the anatomical differences that you would want us to focus on. I mean you mentioned a little bit in your last answer. But is that the entire number? Or is there any other sort of secondary end points or other measures that you would one-off like maybe want to call out?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : And the Phase III, I think the last guidance was that DME and AMD should finish enrollment by the end of this year, sometime in the second half. Is that -- are things still tracking toward that time line?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Okay. And I mean I guess taking a step back a little bit here, how important is the high-dose franchise -- is the high-dose formulation to the franchise over the, I guess, medium to long term?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : And I do want to ask -- I want to pivot off of that and ask a little bit about Protocol W, which was the NIH study that went out pretty recently. And if you could just talk about -- remind us briefly what it showed, but really just talk about its impact on the NPDR population. And perhaps more importantly, what do these data mean for EYLEA use broadly in terms of potential for less frequent dosing? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 22, 2021 / 12:00PM, REGN.OQ - Regeneron Pharmaceuticals Inc at BMO Biopharma Day: Spotlight on Rare Disease and Ophthalmology (Virtual)

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Okay. And we're rapidly running out of time here, so I want to step away from some of the nitty-gritty and move to some bigger picture questions. And I guess is Regeneron a major player in retinal disease come 2030, 2035?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : That's with Alnylam? That's part of the Alnylam leverage?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : So Justin, when can we -- when are we going to start seeing some of these things provide data?

Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst : Great. Well, thank you, guys, both very much. We're over time now, we could easily spend another 20 or 30 minutes on this. But appreciate the time this morning. Thank you guys so much, and have a great rest of your day.